Neurological Responses in Patients with Dentine Hypersensitivity

October 8, 2024 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Identification and Quantification of Neurological Responses in Patients with Dentine Hypersensitivity

Dentine hypersensitivity (also known as sensitive teeth) is a common dental condition in which the dentine, a layer of sensitive hard tissue under the enamel of the teeth, becomes exposed making the teeth sensitive to stimuli, such as hot and cold. It poses a significant challenge for clinicians and affects patients' quality of life.

The overall aim of the study is to understand if a way of measuring brain activity (electroencephalography [EEG]) shows a response to tooth stimulation, and see how these responses may be different in patients with dentine sensitivity.

EEG records brain signals and can provide information about how the brain processes painful stimuli. EEG recording is a non-evasive and painless procedure. It involves using a cap with small sensors called electrodes to pick up brain signals. During the EEG assessment appointment, brain signals will be recorded throughout the duration when cold temperatures and short bursts of air are applied to the tooth. Brain signals recorded during tooth stimulation from participants with and without dentine sensitivity will then be compared to explore if there are any differences.

The investigators hope that EEG responses could be helpful to objectively assess dentine sensitivity, further the understanding of brain processing of dental pain, and allow the comparison of the effectiveness of different treatment options in the future.

This information may help to improve treatments and the quality of life for patients with dentine sensitivity and potentially other types of dental pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Dentine hypersensitivity (DH) is a common dental condition that has been defined as a 'short, sharp pain arising from exposed dentine in response to stimuli typically thermal, evaporative, tactile, osmotic or chemical and which cannot be ascribed to any other form of dental defect or pathology'. Many DH interventions have been investigated over the last 60 years, but a lack of standardisation of pain measurement and objectivity of measures are major limitations for assessing the efficacy of products (or understanding why products fail). A potential solution to this problem is greater understanding of the pain propagation mechanism from controlled stimulus to objective, measurable markers of pain severity.

EEG (electroencephalography) is a non-invasive technique that measures the electrical activity of the brain using the electrodes placed on the scalp. EEG provides information about the brain's electrical activity over time, helping diagnose and understand certain neurological conditions. The investigators have carried out a number of studies using human dental pulp and other human tissue to further understand the mechanisms of pain including pulpal pain.

Evoked potentials are EEG responses to specific stimuli, such as light, sound or heat. Pain-evoked potentials from tooth pulp are evoked potentials specifically related to pain originating from the pulp of a tooth. This type of measurement records the brain's electrical response to a stimulus applied to a tooth, such as thermal stimuli. The resulting EEG recording can provide information about how the central nervous system processes painful stimuli, including the speed and magnitude of the response. It was hypothesised that EEG pain-evoked potentials, if generated and measured in a controlled and repeatable way, can potentially be used (in conjunction with other diagnostic methods) to objectively evaluate the severity of dentine sensitivity and compare the efficacy of different treatment options.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom, S10 2JF
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
        • Contact:
          • Fiona Boissonade, BDS, PhD
        • Contact:
          • Mark Barber, BDS, MFDS RCS, PgCertEd, MPhil
        • Contact:
          • Mahnaz Arvaneh, PhD
        • Contact:
          • Natalie Wong, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients attending routine restorative appointments at Charles Clifford Dental Hospital in Sheffield will be screened as potential eligible participants for the study by members of the direct clinical care team and informed about the study.

Description

Inclusion Criteria:

  1. Adults 18 years and older;
  2. Understands and is willing, able and likely to comply with all study procedures and restrictions;
  3. Accepts the form of the study and signs a declaration of informed consent;
  4. In good health (in the opinion of the clinical dental professional);
  5. A minimum of 10 teeth not including teeth with crowns or bridges from upper right 4 to upper left 4 and lower right 4 to lower left 4;

For patients with dentine sensitivity only (experimental group): self-reported sensitivity in at least 1 tooth; confirmed by response to air puff.

Exclusion Criteria:

  1. Adults currently using maxillary or mandibular orthodontic appliances;
  2. Obvious signs of untreated caries, which in the opinion of the clinical dental professional, will affect the scientific validity of the study;
  3. Periodontal pocket depth ≥4mm in the anterior upper or lower sextants;
  4. Evidence of periodontitis.
  5. Have a history of seizures;
  6. Taking medications that affect brain responses;
  7. Experience damaged skin on the scalp due to cuts, psoriasis, eczema, or other conditions;
  8. Any participant who in the investigator's judgment will not comply with the study protocol;
  9. Any participant who has difficulties in adequate understanding of English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
Patients with dentine sensitivity
Other: Recording of brain activity using electroencephalography (EEG)
Electroencephalography (EEG) responses to sensitivity stimuli applied to the teeth in patients with and without dentine hypersensitivity will be compared
Control
Patients without dentine sensitivity
Other: Recording of brain activity using electroencephalography (EEG)
Electroencephalography (EEG) responses to sensitivity stimuli applied to the teeth in patients with and without dentine hypersensitivity will be compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalography (EEG) responses to tooth stimulation
Time Frame: 1 hour
EEG responses to tooth stimulation will be measured, and EEG responses will be compared between participants with and without sensitive teeth
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Dentine hypersensitivity experience questionnaire (DHEQ) score and EEG responses
Time Frame: 30 minutes

Participants will be asked to complete the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The DHEQ has 48 questions of which 34 comprise an impact scale. The DHEQ score is calculated as the sum of the scores from the questions, with a possible range of 34-238. A higher DHEQ score indicates that dentine hypersensitivity has a greater impact on the participant's quality of life.

DHEQ score will be correlated with EEG responses recorded during tooth stimulation.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

University of Sheffield
HALEON

Investigators

  • Principal Investigator: Fiona Boissonade, BDS, PhD, University of Sheffield

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 11, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH22405
  • 230613 (Other Grant/Funding Number: Haleon)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The summary protocol and results summary will be shared. No identifiable information from the participants will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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